Does Thiamine Help Vomiting and Nausea in Pregnancy?
Primary Purpose
Hyperemesis Gravidarum
Status
Terminated
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
thiamine & promethazine
Sponsored by
About this trial
This is an interventional treatment trial for Hyperemesis Gravidarum focused on measuring nausea, vomiting, pregnancy, thiamine, promethazine, nausea and vomiting in pregnancy
Eligibility Criteria
Inclusion Criteria:
- Pregnant women until 12th week of gestation
- The women visit the ER because of nausea and vomiting
- The women didn't received thiamine yet
Exclusion Criteria:
- Pregnant women over 12th week of gestation
- Women that received thiamine before
- women that allergic to the studied drugs
Sites / Locations
- Gynecologic department, Haemek medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1. thiamine
2. promethazine
Arm Description
Pregnant women until 12 week of gestation who refer to the ER because of nausea and vomiting and didn't improve after hydration, will receive thiamine IV
Pregnant women until 12 week of gestation who refer to the ER because of nausea and vomiting and didn't improve after hydration, will receive promethazine IV
Outcomes
Primary Outcome Measures
the improvement in nausea and/or vomiting after treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT00861523
First Posted
February 18, 2009
Last Updated
June 21, 2015
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT00861523
Brief Title
Does Thiamine Help Vomiting and Nausea in Pregnancy?
Official Title
Comparison Between the Treatment of Thiamine and Promethazine for Improving Vomiting and Nausea in Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Difficulties in recruiting patients
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
5. Study Description
Brief Summary
There are different treatments for nausea and vomiting in pregnancy. According to the ACOG recommendations, promethazine is the first line of parenteral treatment after oral treatment had failed. Thiamine is given to prevent wernicke encephalopathy. This research try to find out whether thiamine helps the vomiting and nausea as well, by comparing the response to thiamine and promethazine in women who suffer from nausea and vomiting in pregnancy.
Detailed Description
Research groups: pregnant women eho visit the emergency room for nausea and vomiting in pregnancy, pregnancy age 12 weeks or less
After basic examinations and hydration, the women will randomized to thiamine or promethazine treatment.
If no improvement is shown, the patient will be treated with the other drug
The patients will be interviewed on their current visit and every two weeks until 14th week of gestation
The interview includes medical history and details about their illness, other treatments, hospitalization etc.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperemesis Gravidarum
Keywords
nausea, vomiting, pregnancy, thiamine, promethazine, nausea and vomiting in pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1. thiamine
Arm Type
Active Comparator
Arm Description
Pregnant women until 12 week of gestation who refer to the ER because of nausea and vomiting and didn't improve after hydration, will receive thiamine IV
Arm Title
2. promethazine
Arm Type
Active Comparator
Arm Description
Pregnant women until 12 week of gestation who refer to the ER because of nausea and vomiting and didn't improve after hydration, will receive promethazine IV
Intervention Type
Drug
Intervention Name(s)
thiamine & promethazine
Intervention Description
thiamine 100 mg IV promethazine 25 mg IV
Primary Outcome Measure Information:
Title
the improvement in nausea and/or vomiting after treatment
Time Frame
2 months after first visit in ER (until 14 week of pregnancy)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant women until 12th week of gestation
The women visit the ER because of nausea and vomiting
The women didn't received thiamine yet
Exclusion Criteria:
Pregnant women over 12th week of gestation
Women that received thiamine before
women that allergic to the studied drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yfat Kadan
Organizational Affiliation
haemek medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic department, Haemek medical center
City
Afula
Country
Israel
12. IPD Sharing Statement
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Does Thiamine Help Vomiting and Nausea in Pregnancy?
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